heavy menstrual bleeding associated with uterine fibroids MedDRA version: 20.0 Level: LLT Classification code 10027331 Term: Menstrual flow altered System Organ Class: 100000004872 MedDRA version: 21.1 Level: LLT Classification code 10046783 Term: Uterine fibroid System Organ Class: 100000004864
Conditions
Sponsors
Myovant Sciences GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A woman will be eligible for enrollment in this study only if all of the following inclusion criteria are met at the time of the Week 52/Baseline visit: 1. Completed the OLE study; 2. Has voluntarily signed and dated the informed consent form prior to initiation of any screening or study-specific procedures for MVT-601-035; Note: Procedures conducted as part of the OLE study that also serve as baseline procedures for this study may be done under the informed consent for the OLE study; 3. Is not expected to undergo gynecological surgery or ablation procedures for uterine fibroids within the study period, including the Safety Follow-up period; 4. Is a responder: Has a menstrual blood loss of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: None of the following criteria may be true for a patient to be eligible for enrollment into this study: 1. Has undergone myomectomy, ultrasound-guided laparoscopic radiofrequency ablation, or any other surgical procedure for fibroids, uterine artery embolization, magnetic resonance-guided focused ultrasound for fibroids, or endometrial ablation for abnormal uterine bleeding at any time during the Parent study or OLE study; 2. Has a weight that exceeds the weight limit of the DXA scanner or has a condition that precludes an adequate DXA measurement at the lumbar spine and proximal femur (e.g., bilateral hip replacement or spinal hardware in the lumbar spine); 3. Anticipates use of any prohibited medications as detailed in the protocol; 4. Has developed any contraindication to treatment with estradiol or norethindrone acetate including: a. Known or suspected breast cancer; b. Known or suspected estrogen-dependent neoplasia; c. Active deep vein thrombosis or pulmonary embolism; d. Active arterial thromboembolic disease, including stroke and myocardial infarction; e. Known anaphylactic reaction or angioedema or hypersensitivity to estradiol or norethindrone acetate; f. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders, including Factor V Leiden; g. Migraine with aura; h. Porphyria; 5. Has current active liver disease from any cause; 6. Has a new diagnosis of a systemic autoimmune disease (e.g., systemic lupus erythematosus, Sjogren’s syndrome, rheumatoid arthritis, polymyositis, systemic sclerosis, psoriasis, psoriaticarthritis, vasculitic syndromes, etc.). Psoriasis not requiring or anticipated to require systemic therapy is permitted; 7. Had any of the following clinical laboratory abnormalities at the OLE study Week 48 visit or any subsequent visit: a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal (ULN); or b. Bilirubin (total bilirubin) > 1.5 x ULN (or > 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome); c. Hemoglobin < 8 g/dL despite iron supplementation; 8. Is currently pregnant or lactating, or intends to become pregnant during the study period or within 4 weeks after the last dose of study drug, or plans to donate ova during the study period or within 8 weeks after the last dose of study drug; 9. Is inappropriate for participation in this study because of conditions that may interfere with interpretation of study results or prevent the patient from complying with study requirements, as determined by the investigator, sub-investigator, or medical monitor; 10. Met a withdrawal criterion in the OLE study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term effect of relugolix 40 mg with estradiol 1.0 mg and norethindrone acetate 0.5 mg (relugolix with E2/NETA) once daily, compared with placebo on menstrual blood loss at Week 76 (24 weeks after randomization).;Secondary Objective: • To evaluate the long-term effect of relugolix with E2/NETA once daily, compared with placebo on menstrual blood loss at 52-weeks after randomization. • To evaluate the effect of retreatment with relugolix with E2/NETA on menstrual blood loss in patients whose menstrual blood volume returned to = 80 mL during the 52-week randomized period. • To evaluate the long-term effect of relugolix with E2/NETA at 52 weeks after randomization on the following: • Achievement of amenorrhea • Resumption of menses • Resumption of heavy menstrual bleeding (HMB) • Hemoglobin • Health-related quality of life as measured by the Short Form (36) (SF-36) • Patient Global Assessment (PGA) for function and symptoms • Work and productivity impact as measured by the Work Productivity •Activity Impairment-Uterine Fibroids (WPAI-UF) •Disease-specific quality of life as measured by the Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL).;Timepoint(s) of evaluation of this end point: 24 week;Primary end point(s): The primary endpoint of the study is the proportion of women who maintain a menstrual blood loss volume of < 80 mL at Week 76 (24 weeks of the randomized treatment period) as measured by the alkaline hematin method. The primary endpoint of responder rate will be evaluated using the mITT Population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: week 52; week 24 and week 52;Secondary end point(s): •Proportion of women who maintain a menstrual blood loss volume of < 80 mL at Week 104 (52 weeks of the randomized treatment period) as measured by the alkaline hematin method; • Change from Week 52/Baseline to Week 76/Week 104 in menstrual blood volume (during the randomized treatment period); • Percentage change from Week 52/Baseline to Week 76 / Week 104 (during the randomized treatment period); • Proportion of patients who responded (menstrual blood loss volume of < 80 mL) to retreatment with relugolix 40 mg and E2/NETA during the retreatment period among placebo patients whose menstrual blood volume had returned to = 80 mL during the 52-week randomized treatment period; • Proportion of women achieving or maintaining amenorrhea; • Proportion of women whose menses has resumed (among those who were amenorrhoeic at Week 52/Baseline); • Time to resumption of menses; • Proportion of women with menstrual blood volume = 80 mL at any time point during the 52-week randomized treatment period; • Time to resumption of menstrual blood volume = 80 mL; • Change from Week 52/Baseline in hemoglobin; • Change from Week 52/Baseline in SF-36 domain and summary component scores; • Change from Week 52/Baseline in PGA for function and symptoms scores; • Change from Week 52/Baseline in the WPAI-UF scores; • Change from Week 52/Baseline in the UFS-QoL Symptom Severity scale and subscales as well as total scores. | — |
Countries
Belgium, Brazil, Chile, Czech Republic, Hungary, Italy, Poland, South Africa, United Kingdom, United States
Contacts
Public ContactVP of cllinical operations
Myovant Sciences GmbH
Outcome results
None listed